Surgical fastener delivery and locking mechanism

ABSTRACT

The invention provides a fastening device for laparoscopic hernia repair. The coordinated operation of two insertion members stabilizes a fastener during closure and locking to ensure that the fastener is locked in the intended location before the device releases from the fastener. One of the insertion members includes a pair of prongs that exhibit a closed configuration when they are disposed in a recess at an end of the fastener. The fastener has a hook at one end and a loop at the other end. The insertion members push the fastener out from the device and through the tissue. A curvature in at least one of the insertion members pushes the hook through the loop all while the prongs are in the recess in the fastener, thereby stabilizing the fastener with respect to the device.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/132,861, filed Apr. 19, 2016, now U.S. Pat. No. 10,117,648 whichclaims priority to, and the benefit of, U.S. Provisional PatentApplication Ser. No. 62/151,631, filed Apr. 23, 2015, the contents ofwhich are incorporated by reference.

FIELD OF THE INVENTION

The invention generally relates to devices for hernia mesh fixation.

BACKGROUND

If a person has a hernia, they may suffer from pain, organ dysfunction,bowel obstruction, or other complications. This occurs when an organprotrudes through the wall that normally contains it. Hernias can occurin a number of parts of the body, and occur commonly in the abdomen. Forexample, the peritoneum that lines the abdomen may push out through aweakened area of the abdominal wall to form a small balloon-like sac.This can allow a loop of intestine or abdominal tissue to push into thesac.

One method of hernia repair involves using a surgical procedure known aslaparoscopy to cover the hernia with a prosthetic mesh and fix it inplace with fasteners. The fasteners are delivered by a fastening deviceconfigured to reach into the abdominal cavity through an incision. Asurgeon inserts surgical implements as well as a laparoscope—a smalltelescope with a camera attached—through small incisions made in theskin, allowing the surgical fastener to be inserted and directed to thehernia. Unfortunately, fastening a hernia mesh via laparoscopic accessis fraught with problems. Fasteners do not always fully close properlyin the right position and orientation to fasten the mesh properly. Ifthe surgeon realizes this during the procedure, additional fasteners maybe deployed. However, an overabundance of foreign objects is thought tocontribute greatly to patient pain. If the surgeon does not realize thatsome of the fasteners have failed to fasten, then the entire proceduremay require a do-over.

SUMMARY

The invention provides a fastening device that can be used to deliver afastener to hernia through a laparoscopic incision and that uses thecoordinated operation of two insertion members to stabilize the fastenerduring closure and locking to ensure that every fastener is fully closedand locked precisely in the intended location before the device releasesfrom the fastener. One of the insertion members includes a pair ofbiased prongs that are held together when they are pushed into a recessat an end of the fastener. The fastener has a hook at one end and a loopat the other end. The insertion members push the fastener out from thedevice and through the tissue. A curvature in at least one of theinsertion members pushes the hook through the loop all while the prongsare held in the recess in the fastener, thereby stabilizing the fastenerwith respect to the device (which is typically being held and controlledby the physician). After the hook is locked into the loop, the insertionmembers are retracted. Upon retraction from the recess, the prongs arepushed aside by the insertion members and/or the fastener, therebycreating a clearance for the closed, locked fastener to pass through asthe insertion members are retracted away from closed, locked fastenerand back into the device. Thus the device gives the physician theability to control and stabilize the fastener during the entire closingand locking processes. The physician has direct mechanical contactgrasping the fastener, which contact is maintained until after thefastener is closed and locked. Since the device gives the physician theability to control and stabilize the fastener during the entire closingand locking process, the device will always fully and properly close andlock the fastener in the right position and orientation to fasten themesh properly. Since the fasteners are always positioned and fastenedproperly, the physician does not need to deploy additional fasteners tocompensate for misfires and much patient pain is avoided. Additionally,since hernia meshes are consistently fastened properly during theprocedure, costly and painful do-overs are avoided.

In certain aspects, the invention provides a suturing device having aplurality of fasteners disposed within an applicator section. Each ofthe plurality of fasteners is formed as a single piece with twoterminating ends, where one of the two terminating ends has a hook andthe other one of the two terminating ends has a loop. Further, thedevice includes first and second members movable out of and into theapplicator section to deliver, one at a time, each of the fasteners. Thefirst insertion member is configured to engage the hook of one of thefasteners, penetrate the patient's tissue, and carry the hook throughthe patient's tissue when the first member is moved out of theapplicator section. The second insertion member is configured to engagethe loop of that fastener, penetrate the patient's tissue, and carry theloop through the patient's tissue when the second member is moved out ofthe applicator section. One of the insertion members includes a pair ofprongs that are positioned together when they are pushed into a recessat an end of the fastener. The insertion members push the fastener outfrom the device and through the tissue. A curvature in at least one ofthe insertion members pushes the hook through the loop all while theopen-biased prongs are held in the recess in the fastener, therebystabilizing the fastener with respect to the device (which is typicallybeing held and controlled by the physician). After the hook is lockedinto the loop, the insertion members are retracted. Upon retraction fromthe recess, the prongs are separated from one another (e.g., by beingdragged over, and pushed apart by, either the closed fastener or thehook insertion member), creating a clearance for the closed, lockedfastener to pass through as the insertion members are retracted awayfrom closed, locked fastener and back into the device.

Aspects of the invention provide a device for delivering a plurality offasteners, one at a time, into tissue of a patient. The device includesa handle including a trigger, a shaft extending from the handle anddimensioned for insertion into a patient's abdomen through an incisionin the abdomen, and an applicator section at a distal end of the shaft.The plurality of fasteners are disposed within the applicator sectionand each of the plurality of fasteners is formed as a single piece witha hook at one end and a loop at the other end. The device includes firstand second members operably coupled to the trigger. Activation of thetrigger by a user causes (i) the first member to engage the loop of oneof the fasteners carry the loop through the patient's tissue, (ii) thesecond member to engage the hook of that fastener, carry the hookthrough the tissue, and pass the hook through the loop, thereby lockingthe fastener into a closed loop in the tissue while the loop remainsengaged by the first member, and (iii) the first and second members toretract into the applicator section leaving the closed fastener in thetissue. The shaft is preferably dimensioned for insertion into theabdomen through a trocar placed in the an incision. Preferably, thefirst and second members are configured to penetrate a prosthetic meshand the patient's tissue.

In some embodiments, a distal tip of the first member defines a pair ofprongs configured to be inserted into a recess at a distal end of theloop of the fastener. The pair of prongs is held in the recess wheninserted into the recess. The distal tip of the first member isconfigured to define an opening corresponding to the loop while the pairof prongs is held together by the recess. The distal tip of the firstmember (the pair of prongs) includes an elastic material that biases thepair of prongs into a first configuration (e.g., closed) but allows themto be pushed elastically into a second conformation (e.g., open) todefine a gap between the pair of prongs. Retraction of the first membermay include removing the pair of prongs from the recess and withdrawingthe distal tip of the first member by allowing the hook end of thefastener to pass through the gap between the pair of prongs.

In certain embodiments, at least one of the first and second members hasa flexible, pre-shaped portion that moves along a curved path. Theflexible portion remains straight when disposed in the shaft and, uponthe activation of the trigger, extends from the shaft and moves alongthe curved path by assuming a curved shape. That one of the first andsecond members may move along a path that is both straight and curvedoutside of the shaft.

The first and second insertion members may be operably coupled to thetrigger by first and second push rods that each have a distal endengaged with its respective insertion member and a proximal end engagedwith a slot wheel in the handle.

In some embodiments, the device is configured to deliver fasteners ofdifferent sizes to different penetration depths within the patient'stissue. Optionally, the applicator section is configured to receive acartridge loaded with the plurality of fasteners. For example, thecartridge may be from a set of cartridges, at least two of thecartridges in the set carrying fasteners of a different size.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a fastening device for hernia repair.

FIG. 2 shows articulation of a shaft of the device.

FIG. 3 illustrates navigation of the applicator section to the herniamesh.

FIG. 4 shows articulation of the applicator section.

FIG. 5 shows a fastener for use with a device of the invention.

FIG. 6 shows the fastener 250 as it is being closed.

FIG. 7 shows the fastener 250 in a locked configuration.

FIG. 8 gives a close-up view of the applicator section of the device.

FIG. 9 shows the loop insertion member delivering the fastener.

FIG. 10 gives two views of the loop insertion member.

FIG. 11 shows the prongs of insertion member captured by a recess on thefastener.

FIG. 12 shows applicator section closing the fastener.

FIG. 13 illustrates retraction of the insertion members.

FIG. 14 shows the fully retracted insertion members.

FIG. 15 shows mechanical components in the handle of the fasteningdevice.

FIG. 16 shows the structure of the fastener feeder.

FIG. 17 illustrates an assembled fastener feeder mechanism.

FIG. 18 shows the positioning of a fastener in the fastener feeder.

FIG. 19 shows shaft cap in an end the shaft.

FIG. 20 shows retraction of the drive comb.

FIG. 21 shows the drive comb engaged with the pre-formed fasteners.

FIG. 22 shows the drive comb pushing one of the pre-formed fasteners.

FIG. 23 shows the next the fastener positioned at the collection slots.

FIG. 24 shows the comb driver assembly.

FIG. 25 shows hook engagement.

FIG. 26 depicts a pulling back step.

FIG. 27 shows release.

FIG. 28 shows advancement of the fastener.

FIG. 29 shows the articulation joint FIG. 30 shows a bend in the shaftof the device.

FIG. 31 shows a cartridge-style carrier for fasteners.

FIG. 32 shows a thin spacer for use with larger fasteners.

FIG. 33 shows a spacer for use with intermediate fasteners.

FIG. 34 shows a long spacer for use with small fasteners.

DETAILED DESCRIPTION

The invention relates to a new locking concept for use with hernia meshfasteners. In some prior art devices, the insertion mechanisms arepulled away before the fastener is fastened, raising the specter of riskthat an unfastened fastener will be left in tissue. Using a device ofthe invention as described herein that risk is avoided by holding theloop in place by the loop inserter while the hook is passed thru it.Only once the hook is completely inserted into the loop and the fasteneris locked the insertion needles are retracted. In order to accomplishthis, a new insertion member with prongs is included in the device. Thenew insertion member allows for its retraction while the hook of thefastener is position inside the loop.

In certain embodiments, the prongs comprises a super-elastic materialsuch as the nickel titanium alloy Nitinol. The prongs may be biased tothe closed position but are temporarily deformed to the open position bybeing retracted back into the delivery device after delivery, the prongbeing spread open by passing over the delivered fastener or one of thedelivery members.

In some embodiments, the prongs define a pair of open-biased prongs thatinclude an elastic material (e.g., Nitinol) defining two flexible prongswhich converge at the tip of the insertion member. In the open-biasedembodiment, the rest position for the prongs is opened, but a recess onthe fastener holds the prongs together during delivery. When withdrawnfrom the fastener, the prongs spring open to give clearance for thefastener.

In either embodiment, the two prongs can be separate or spaced apart attheir tips and can flex laterally, thus creating a gap. When theinsertion member is within device, the tip can be inserted into a pocketat one end of the fastener and can push that end into the tissue. Whilethe insertion member is retracted it slides out of the pocket and theprongs separate laterally as a result of sliding on top of the hookinserter or the fastener body.

FIG. 1 shows a fastening device 100 according to certain embodiments.Fastening device 100 is adapted to place and secure at least onefastener inside a tissue during a minimal invasive surgical operation.Fastening device 100 has an applicator section 101 and a handle section102 connected via shaft 103. Applicator section 101 is adapted to passthrough an incision or standard trocar, and to make contact with, andinsert a fastener into, the tissue. Because the device is for minimallyinvasive surgery, the shaft preferably has a length L of at least 15 cmand has a diameter D of less than 1 cm. Applicator section 101 operatesas a fastener carrier by being operably connected to shaft 103 (e.g.,either one can be partially disposed within the other, they can bemanufactured and assembled together, etc.).

Handle section 102 allows a practitioner to control fastenerapplication. Handle section 102 includes trigger 105, which maygenerally include a lever mechanism. Operation of trigger 105 deliversand fastens a fastener as described below.

In certain embodiments, shaft 103 is articulated around an articulationjoint 104 in order to place a fastener inside the tissue in a correctangle in respect to the tissue surface

FIG. 2 shows articulation of shaft 103. Handle 102 includes articulationknob 106 adapted to control the articulation. Since shaft 103 may bebent at articulation joint 104, a physician may navigate the applicatorsection 101 to the hernia mesh within the abdomen.

FIG. 3 illustrates navigation of the applicator section 101 to thehernia mesh within the abdomen. Device 100 is used for securing a herniamesh 400 to the innermost layer of abdominal wall 401 duringlaparoscopic hernia repair surgery. In general, the outermost layer ofthe abdominal wall is the skin, followed by two layers of fibrousconnective tissue (the campers fascia then the Scarpas fascia), threelayers of muscle (the external oblique muscle, the internal obliquemuscle, and the transverse abdominal muscle), a layer of fat (thepreperitoneal fat), and then the peritoneum—a membrane that surroundsthe abdominal cavity. Methods include inserting a distal portion offastening device 100 into a patient's abdominal cavity through a trocar402 or through an incision.

FIG. 4 shows articulation of the applicator section 101 via articulationknob 106. Distal tip 301 is pressed against hernia mesh 400 and a singlefastener is delivered through the tissue and hernia mesh 400 and securedin place by pressing lever 107 on handle 102. The device 100 is removedfrom the abdomen through the surgical incision. The device 100 operateswith one or a plurality of pre-formed sutures formed to interoperatewith mechanisms of the applicator section 101.

FIG. 5 shows a fastener 250. Preferably, the fastener 250 is pre-formedto have substantially the shape shown in FIG. 5. The fastener 250includes an extended body 251. A first end 253 of the fastener includesa hook 269. The second end 252 of the fastener includes a loop 265 aswell as a sloped portion 277 that can be driven through soft tissue. Thehook end may be pushed through the loop 265.

FIG. 6 shows the fastener 250 as it is being closed and the hook 269 isbeing passed through the loop 265. After the fastener is closed, it mayfurther be locked closed by drawing the neck of the hook 269 up into thenarrowest portion of the loop 265. Additionally, FIG. 6 shows a recess601 on a back surface of insertion slope 277.

FIG. 7 shows the fastener 250 in a locked configuration. The fastener250 includes insertion slope 277 and at least one barb 269 that aredimensioned to operate with the insertion members of device 100. Firstmember 253 includes a hook and second member 252 includes a loop. Thefastener 250 is configured to be carried and delivered by the applicatorsection 101 of device 100.

FIG. 8 gives a close-up view of the applicator section 101 of device100. Just visible within the applicator section 101 is the portion offastener 250 where the loop 265 is located. This is the disposition ofthe fastener 250 when the distal end of the shaft 103 is pressed againstthe tissue (e.g., FIG. 4). Activation of the trigger 105 causes theinsertion members to collect and deliver the fastener 250.

FIG. 9 shows the loop insertion member 357 collecting and delivering thesecond end 252 of the fastener 250. Specifically, upon activation of thetrigger, the hook insertion member 352 is collecting and delivering thefirst end 253 of the fastener 250 to engage the hook of that fastenerand carry the hook through the tissue. The loop insertion member 357engages the second end of the fastener 250, thereby engaging the loop265 of the fastener 250 to carry the loop through the patient's tissue.The loop insertion member 257 includes a pair of elastic prongs.

FIG. 10 gives two views of the loop insertion member 357. The view onthe right shows the elastic prongs 191 in the open conformation. Theview on the left illustrates the conformation that the prongs assumewhen they are captured by recess 601 (visible in FIG. 6).

FIG. 11 shows the prongs of insertion member 357 captured by recess 601on the loop end of a fastener 250. In operation of device 100, thesuture 250 is collected by the hook inserter 352 and the loop inserter357.

FIG. 12 shows applicator section 101 operating to close the fastener 250within tissue. The loop 265 is deployed straight inside the tissue andthe hook 269 is inserted into the loop. The hook 269 passes through theloop 265 locking the fastener into a closed loop in the tissue while theloop remains engaged by the first member. The two insertion membersstabilize the fastener 250 during closure and locking to ensure thatevery fastener 250 is fully closed and locked precisely in the intendedlocation before the device releases from the fastener. The elasticprongs 191 are disposed together in recess 601. As shown in FIG. 12, theinsertion members have pushed the fastener 250 out from the device andthrough the tissue. A curvature in the hook insertion member 352 pushesthe hook 253 through the loop all while the prongs 191 are held in therecess 601 in the fastener 250, thereby stabilizing the fastener 250with respect to the device 100 while the device is being held andcontrolled by the physician. After the hook is locked into the loop, theinsertion members are retracted.

FIG. 13 illustrates retraction of the insertion members. The loopinserter is retracted back, and the prongs 191 flex laterally while theyslides over the hook insertion member 352.

FIG. 14 shows the loop inserter 357 and the hook inserter 352 fullyretracted, leaving the fastener 250 locked inside the tissue.

In certain embodiments, a reticulation of the distal end of fasteningdevice 100 allows the distal tip to be rotated around its longitudinalaxis. This can allow the application of fasteners in various orientationin respect to said fastening device 100.

FIG. 15 shows components of a handle of a fastening device. As can beseen in FIG. 15, one or more of push rod 135 are linked to one or moreof translator bar 131. Translator bar 131 has a pin 127 fixed into aslot 123 of slot wheel 115. As shown in FIG. 15, applicator 100 includesa second slot wheel 119. Additional slot wheels may be included. Therotation of the slot wheel is driven through gear mechanism 111 by ageared face 107 of trigger 105.

By the relationship of these parts, when trigger 105 is squeezed, eachof the slot wheels rotate. Because each slot (e.g., slot 123) isirregularly shaped (e.g., not a circle concentric with slot wheel 115),the corresponding translator bar translates independently relative tohandle 102 and with acceleration defined by the disposition of the slot.The independent translation of translator bar 131 causes the independenttranslation of push rod 135 which cause the independent action of hookinsertion member 352 and loop insertion member 357, as described above.

In certain embodiments, the series of coordinated motions of theinsertion needles, and the delivery of a fastener, is operated andcoordinated electronically. For example, applicator device 100 caninclude servomotors operably connected to a governing circuit and/orchip. A motor can drive the slot wheels. Or, motors can drive each pushrod as governed by a chip executing instructions provided, for example,by a tangible, non-transitory computer memory such as, for example, afield-programmable gate array or a disc drive.

FIG. 16 shows the structure of the fastener feeder 919. Hook insertionmember 352 lies under front feeder cover 941, which includes marker slot943. Front cover 941 covers hold comb 945. Fastener stack 955 includes aplurality of the fastener 250 extending from fastener support slide 953,which also includes marker pin 947. Front cover 941 and back cover 959covering and holding the fastener stack 955 and the fastener support953, said front and back cover can be at least partially, substantially,or entirely encapsulated within the shaft cover 949 and terminate atshaft cap 939. Comb driver assembly 951 with comb driver hook 948operates drive comb 957, as described below. Fastener feeder 919includes loop insertion member 357 disposed near fastener spreader 961.Shaft cap 939 includes a loop collection slot 963 and a hook collectionslot 964. Fastener feeder 919 functions to deliver one the fastener 250from fastener stack 955 per operation of device 100.

FIG. 17 illustrates an assembled fastener feeder 919. In operation, thecomb driver assembly 951 first generates a single up and down stroke ofthe back drive comb at the end of each application cycle. As a responseto the stroke, the entire fastener stack 955 is pushed forward by thedrive comb 957. During this process the hold comb 945 (not shown)prevents a downward movement of the pre-formed fasteners 250 in fastenerstack 955. Once the fasteners stack 955 is pushed upward (e.g.,forward), the last the fastener 250 is spread by the fastener spreader961 and is positioned at the collection slots 963 and 964, ready to becollected by the insertion needles 352 and 357 during the nextapplication cycle. Each the fastener 250 supports the next the fastener250 and prevents the lateral movement of its middle while it is pushedby drive comb 957. The last the fastener 250 is supported by thefastener support slide 953. Fastener support slide 953 is pushed by thedrive comb 957 together with the fasteners. A marker pin 947 mayprotrudes to the outer surface of the shaft, through the marker slots atthe feeder covers 941, to indicate to the surgeon how many fastenersremains in the device.

FIG. 18 shows the positioning of a fastener 250 in fastener feeder 919.The arms of spreader 961 are flexible and can flex toward the center ofthe shaft in order to allow the ends of the fastener 250 to exit fromthe device. Spreader 961 also provides resistance in order to allow theintegration between needle and the fastener 250 and hold the last thefastener 250 in place before its application. The last the fastener 250is pushed forward against the spreader 961 by the drive comb 957. As aresult, the ends of the fastener 250 are spread into the collectionslots 963 and 964 from which they are collected by the insertion needlesduring the insertion process. The bottom side of the spreader 961 insloped in order to allow the extraction of the fastener 250 once it wascollected by the insertion needles.

FIGS. 19-23 show the advancement of a the fastener 250 through fastenerfeeder 919. FIGS. 19-23 are cross-sections of a distal end of fastenerfeeder 919 and they depict a loading of a new the fastener 250 into thecollection slots 963 and 964 once a the fastener 250 is applied.

FIG. 19 shows shaft cap 939 in an end of shaft cover 949 with fastenerspreader 961 therein. In the illustrated embodiment, fastener feeder 919provides a fastener carrier operably connected to cover 949 of shaft103. In a related embodiment (not illustrated), front cover 941 and backcover 959 provide at least part of an outer surface of the device andare operably connected to a portion of shaft 103 by a suitable meanssuch as adhesive, threading, press-fit, co-molding, heat staking, etc.Also visible is the fastener 250, being controlled by drive comb 957 andhold comb 945. In an initial stage in FIG. 19, after the first thefastener 250 is collected and inserted into the tissue, the next thefastener 250 is placed below the collection slots 963 and 964.

FIG. 20 shows retraction of the drive comb 957 while the hold comb 945is holding the fastener stack 955 in place. The teeth of the drive comb957 are bent while they are climbing over the fastener stack 955.

FIG. 21 shows drive comb 957 engaged with bottom section of thepre-formed fasteners in fastener stack 955.

FIG. 22 shows drive comb 957 pushing one of pre-formed fasteners 250forward and toward the spreader 961 while climbing over the teeth of thehold comb 945 (which are bent during the process).

FIG. 23 shows the next the fastener 250 positioned at the collectionslots 963 and 964 and is ready to be collected by the insertion needles352 and 357.

FIGS. 24-28 depict the operation of the comb driver mechanism offastener feeder 919.

FIG. 24 shows comb driver assembly 951 providing a connection betweencomb driver hook 948 plus comb driver slide 975 and drive comb 957.Release slope 977 and release bulge 976 release the comb driver hookfrom the hook insertion member. Comb driver spring 981 can be seen byhook slot 983. The comb driver hook 948 is connected to the comb driverslide 975 by a flexible pin, allowing its rotation. FIG. 24 shows aninitial stage, in which hook inserting needle 352 is positionedbackward.

FIG. 25 shows hook engagement. Once an application cycle starts, hookinsertion member 352 moves forward. Once the hook slot 983 is positionedin front of the comb driver hook 948, comb driver hook 948 springs intohook slot 983.

FIG. 26 depicts a pulling back stage. At the final stage of theapplication cycle, the hook insertion member 352 moves back whilepulling the back the comb driver slide 975 and the drive comb 957 whilepressing the comb driver spring 981. During this movement the comb teethare engaged with pre-formed fasteners 250.

FIG. 27 shows release. Once the release bulge 976 reaches the releaseslope 977, release bulge 976 is pushed laterally and removes the hook948 out of the hook slot 983.

FIG. 28 shows advancement of the fastener 250. The compressed spring 981pushes the comb driver 951 and the drive comb 957 forward whileadvancing the entire fastener stack 955.

During operation, the fastener 250 is delivered by pushing each of itsends into tissue. As shown above, delivery is coordinated by theindependent translation of push rods operably coupled to hook insertionmember 252 and loop insertion member 357, which is triggered through theuse of trigger 105. Coordination of delivery involves extending hook endof the fastener 250 away from applicator section 101 while alsoextending loop end of the fastener 250 and bringing the two ends of thefastener together (e.g., through the operation of a shape memorymaterial in loop insertion member 357). Methods include using theneedles to drive the fastener 250 into tissue and retracting the needlesso they disengage from the fastener 250 leaving it in place and fastenedin a closed loop, closing the wound.

The invention also provides methods for securing a medical prosthesis totissue. Securing the prosthesis is accomplished through delivering afastener to a target tissue that has a prosthesis applied to it, usingapplicator 100. Methods include inserting a distal portion of fasteningdevice 100 into a patient's abdominal cavity through a trocar or throughan incision. The distal end is pressed against the hernia mesh and afastener is delivered through the tissue and hernia mesh and secured inplace by pressing trigger 105 on handle 102. Shaft 103 is then removed.

Delivery according to the methods of the invention causes the first endof the body to mate with and be retained by the second end of the body,thereby forming the fastener into a closed configuration and securingthe prosthesis to the tissue. The prosthesis can be secured by employinga fastening structure provided by the first and second members.

During delivery, hook insertion member 352 interfaces with second member252 via needle interface hook 271. Loop insertion member 357 extendsfrom insertion tube 356 and similarly interacts with first member 253via loop interface hook 261.

Loop insertion member 357 is extended out from applicator section 101and curves to guide the fastener through the prosthesis. Delivery iscoordinated by the independent translation of push rods (discussedabove) operably coupled to hook insertion member 252 and loop insertionmember 357. Coordination of delivery involves extending hook end of thefastener 250 away from applicator section 101 while also extending loopend of the fastener 250 and bringing the two ends of the fastenertogether (e.g., through the operation of a shape memory material in loopinsertion member 357). Methods can include pushing a fastener through aback surface of needle interface hook 271 and loop interface hook 261with a corresponding insertion needle. The needles can drive thefastener 250 into the prosthesis (e.g., hernia mesh). The needles arethen retracted, leaving the fastener 250 in place and fastened in aclosed loop securing the prosthesis to the tissue.

One insight of the invention is that in hernia mesh 400 fixation, it isimportant that a fastener should be anchored to a fascia layer. Fasciais a layer of fibrous tissue containing closely packed bundles ofcollagen. Fascia provides a connective tissue that surrounds muscles,groups of muscles, blood vessels, and nerves. This is the layer to whichsurgeons affix a hernia mesh and the fastener design should form astrong anchor to that layer.

In each patient the thickness of the pre-peritoneal fat layer isdifferent. For example, the first fascia layer in obese patients issignificantly deeper than in slim patients. Some existing fixed-lengthhernia tacks favor shorter lengths so that, in slim patients, they willnot penetrate all the way through the abdominal wall and to the skin.Fasteners that are too small, however, will not anchor into the fasciain some sites or in obese patients for whom the pre-peritoneal fat layeris substantially thick. One insight of the invention is that there is aneed for variable depth fasteners that can be delivered by a singledevice to accommodate variations in the abdominal wall of differentpatients and variation in areas of the abdominal wall at any treatmentsite. A fastening device of the invention is provided that can fix ahernia mesh despite variations in tissue with fasteners that pass beyondthe hernia mesh by a controlled amount (e.g., between about 3millimeters and 15 millimeters). By provided fasteners that extendedonly about a couple of millimeters past the hernia mesh, a fasteningdevice of the invention provides good fixation to prevent recurrence ofthe hernia. By avoiding use of a fastener that is too long,post-operative pain is minimized. Considerations in fastener operationare discussed in Abhishek, et al., 2012, Laparoscopic Umbilical HerniaRepair: Technique Paper, ISRN Minimally Invasive Surgery, pp. 1-4,Article ID 906405, and in Nguyen, et al., 2008, Postoperative Pain AfterLaparoscopic Ventral Hernia Repair: a Prospective Comparison of ClipsVersus Tacks, JSLS 12:113-116, the contents of each of which areincorporated by reference.

In certain embodiments, a leading edge of either or both of theinsertion needles is at least partially sharpened to aid in penetrationof tissue. Each of needle interface hook 271 and loop interface hook 261can have a back surface that gets pushed by the corresponding insertionneedle. Alternatively or additionally, either needle interface hook caninclude a slot and a portion of the corresponding insertion needle canbe dimensioned to engage the slot. By these means, the needles can drivethe fastener 250 into tissue and when the insertion needles areretracted, they disengage with the fastener 250 leaving it in place andfastened in a closed loop.

With reference to FIG. 2, applicator section 101 and shaft 103 caninclude articulation joint 104. FIGS. 29 and 30 show a structure bywhich articulation joint 104 can allow shaft 103 to bend while stilloperating according to the embodiment described herein.

FIG. 29 shows that articulation joint 104 includes a plurality of livinghinge 913. A living hinge 903 generally includes a flexible portion anda flange 901. One or more of push rod 909 extend through joint 104generally disposed so that, where there are multiple push rods, an axisof each push rod exhibits the same radius as the others when hinge 104is bent. Flange 901 can be provided to limit the radius of curvature ofhinge 104 to optimize functionality of applicator section 101, forexample, by preventing the push rods from being bent too much.

Hinge 104 further includes an articulation cable 905 with anarticulation wire ending 917 disposed on a distal side of hinge 104 fromhandle 102 (not pictured). When articulation wire 917 is pulled by amechanism in handle 102 (discussed in more detail below), articulationwire ending 917 exhibits a compressive force on hinge 104, causing it tocompress on one side, while expanding on the other, thus forming a bendin shaft 103.

FIG. 30 shows a bend in shaft 103. Articulation joint 104 can be madewith any suitable material known in the art such as, for example, anelastically deformable material. In certain embodiments, the material isa low friction material such as PTFE to minimize friction between joint104 and push rod 909.

The fastening device is designed and dimensioned for use in laparoscopicor endoscopic surgery. Shaft 103 is dimensioned for use with endoscopictubes and apparatuses. The device can also be inserted through anincision or trocar and used within a body. In certain embodiments,fastening device 100 can hold at least one of the fastener 250 in acartridge 801 that can be interchangeably loaded into applicator section101 of fastening device 100.

FIG. 31 shows a cartridge-style carrier 801 having an insertion end 803and a spacer 807 oriented for insertion into applicator section 101. Atthe end of applicator section 101, FIG. 31 shows receiving pad 809 withloop insertion member 357 visible disposed therein. As can be seendepicted in the distal end of cartridge 101, second member 252(specifically, a portion of needle interface hook 271) is held in aslot, oriented to interface with hook insertion member 352 in applicatorsection 101. Receiving pad 809 can include an interior shape dimensionedto receive insertion end 803.

Cartridge-style carrier 801 has a structure that cooperates with themechanical structure of fastening device 100 so that the device candeliver and fasten fasteners within a body of a patient. Cartridge-stylecarrier 801 accommodates fasteners of different sizes.

In some embodiments, cartridge 801 uses an interchangeable spacer andspacers of different sizes accommodate different fasteners. In certainembodiments, each cartridge holds a number of fasteners of the samesize. Spacers are provided to control the distance between the tip ofthe device and the tissue (or prosthesis) surface. For example, forsmaller fasteners, a larger spacer is provided to prevent the fastenerfrom penetrating too deeply into the tissue. Similarly, for largerfasteners, a smaller spacer allows for good penetration depth of thefastener.

FIG. 32 shows a thin spacer 806 for use with larger fasteners. In someembodiments, the spacers are not interchangeable but instead formed aspart of a disposable cartridge 801.

FIG. 33 shows a spacer 807 for use with intermediate fasteners.

FIG. 34 shows a long spacer 808 for use with small fasteners. As shownin FIGS. 31-34, a spacer may include a fastener release slot disposed atan end of the body of the cartridge. In certain embodiments, cartridge801 can be inserted into an end of an shaft 103 via insertion end.Spacers 806, 807, and 809 each provide a part of a fastener carrieroperably connected to and at least partially disposed within shaft 103and carrying a plurality of the fastener 250.

As can be seen in FIG. 31, when cartridge-style carrier 801 is insertedinto shaft 103, second member 252 makes contact with hook insertionmember 352 via needle interface hook 271 and first member 253 makescontact with loop insertion member 357. The fastener 250 is delivered totissue by the action of push rods that drive the insertion needles. Eachpush rod, and thus each needle, translates parallel to an axis of shaft103 relative to each other as well as to member 103. In someembodiments, the fasteners are stacked one on top of the other insidecartridge 801; during each fastener application cycle, a single fasteneris connected to the said insertion needles and then inserted into thetissue. At the end of the application cycle, a fastener is advanced tothe top of the cartridge in preparation to the next application cycle.In another embodiment cartridge-style carrier 801 includes an indicatorwhich visually indicates to the surgeon the quantity of fasteners thatremains in the cartridge. Motion of the push rods is governed by themechanical structure of applicator 100.

Where shaft 103 includes articulation joint 104, articulation knob 106controls the flexure of joint 104. Knob 106 is rotated by a user (e.g.,with a thumb). During the rotation, articulation cable 905 (shown inFIGS. 29 & 30) is wrapped around the knob's axis, pulling it toward thehandle, articulating joint 104. Knob 106 can include one or more ofsocket 139 adapted to fit a ball plunger in place once a desired degreeof articulation is obtained.

The invention further provides methods for closing a wound that involvedeploying fastening device 100 to deliver a fastener to a wound. Woundclosure according to methods of the invention involves positioning thedelivery tip close to the wound. Where the wound is inside the body, theshaft 103 is inserted through an incision, trocar, or endoscopicchannel. A fastener is delivered and formed into a closed configurationby device 100.

When a practitioner depresses trigger 105, loop insertion member 357extends from insertion tube 356 and interacts with first member 253 vialoop interface hook 261. Hook insertion member 352 has and maintains asubstantially straight conformation as it assists in driving a hook endof the fastener 250 into tissue. When loop insertion member 357 isextended out from applicator section 101, it curves to guide thefastening of the fastener.

INCORPORATION BY REFERENCE

References and citations to other documents, such as patents, patentapplications, patent publications, journals, books, papers, webcontents, have been made throughout this disclosure. All such documentsare hereby incorporated herein by reference in their entirety for allpurposes.

EQUIVALENTS

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The foregoingembodiments are therefore to be considered in all respects illustrativerather than limiting on the invention described herein. Scope of theinvention is thus indicated by the appended claims rather than by theforegoing description, and all changes which come within the meaning andrange of equivalency of the claims are therefore intended to be embracedtherein.

What is claimed is:
 1. A device for fastening a hernia mesh, the devicecomprising: a handle including a trigger; a shaft extending from thehandle and dimensioned for insertion into a patient's abdomen through anincision in the abdomen; a first insertion member and a second insertionmember disposed within the shaft; and a fastener comprising a loop endheld by the first insertion member and a hook end held by the secondinsertion member, wherein the first insertion member comprises a pair ofprongs positioned together within a recess at the loop end of thefastener, wherein operation of the trigger causes the first and secondinsertion members to push the fastener out from the device and throughthe tissue, push the hook end through the loop end to lock the fastenerclosed, and retract to release the fastener, wherein as the first andsecond insertion members are retracted, the pair of prongs separate fromone another to create clearance for the locked fastener to pass through.2. The device of claim 1, wherein when the pair of prongs is positionedtogether within the recess at the loop end of the fastener, the pair ofprongs defines an opening corresponding to a loop on the loop end of thefastener.
 3. The device of claim 1, wherein the distal tip of the firstmember comprises a super-elastic material that biases the pair of prongstogether, and when withdrawn from the recess, the pair of prongs areopened by being dragged over the second member.
 4. The device of claim3, wherein the super-elastic material comprises nickel titanium alloy.5. The device of claim 1, wherein retraction of the first memberincludes removing the pair of prongs from the recess and withdrawing thedistal tip of the first member by allowing the hook end of the fastenerto pass through a gap between the pair of prongs.
 6. The device of claim5, further comprising a plurality of the fasteners disposed within anapplicator portion of the shaft.
 7. The device of claim 6, whereinactivation of the trigger by a user causes the first insertion member tocarry the loop end through the patient's tissue, the second insertionmember to pass a hook of that fastener through the loop, thereby lockingthat fastener closed, and the first and second members to retract intothe applicator section leaving the closed fastener in the tissue.
 8. Thedevice of claim 1, wherein the shaft is dimensioned for insertion intothe abdomen through a trocar.
 9. The device of claim 1, wherein at leastone of the first and second insertion members comprises a flexible,pre-shaped portion that remains straight when disposed in the shaft and,upon the activation of the trigger, extends from the shaft and movesalong the curved path by assuming a curved shape.
 10. The device ofclaim 9, wherein the first and second members are operably coupled tothe trigger by first and second push rods, wherein each push rodcomprises a distal end engaged with its respective member and a proximalend engaged with a slot wheel in the handle.
 11. The device of claim 1,wherein the applicator section is configured to receive a cartridgeloaded with the plurality of fasteners.
 12. The device of claim 11,wherein the cartridge is from a set of cartridges, at least two of thecartridges in the set carrying fasteners of a different size.
 13. Thedevice of claim 12, wherein the device is configured to deliverfasteners of different sizes to different penetration depths within thepatient's tissue.
 14. A method for securing a medical prosthesis totissue, the method comprising: delivering a fastener to a target tissuethat has a prosthesis applied to it, using a device that includes: ahandle including a trigger; a shaft extending from the handle anddimensioned for insertion into a patient's abdomen through an incisionin the abdomen; a first insertion member and a second insertion memberdisposed within the shaft; and a fastener comprising a loop end held bythe first insertion member and a hook end held by the second insertionmember, wherein the first insertion member comprises a pair of prongspositioned together within a recess at the loop end of the fastener. 15.The method of claim 14, further comprising, by one operation of thetrigger: pushing, by means of the first and second insertion members,the fastener out from the device and through the tissue, pushing thehook end of the fastener through the loop end, locking the fastener in aloop, and retracting to release the fastener, wherein as the first andsecond insertion members are retracted, the pair of prongs separate fromone another to create clearance for the locked fastener to pass through.16. A method for securing a hernia mesh to tissue, the methodcomprising: inserting a distal portion of a shaft of a fastening deviceinto a patient's abdominal cavity through an incision by holding ahandle on a proximal end of the shaft to manipulate the fasteningdevice; pressing a distal end of the shaft of the device against thehernia mesh; operating a trigger on the handle to deliver a fastenerthrough the hernia mesh and into the tissue to secure the fastener inplace, wherein the fastener comprises a loop end held by a firstinsertion member disposed within the shaft and a hook end held by asecond insertion member disposed within the shaft, wherein the firstinsertion member comprises a pair of prongs positioned together within arecess at the loop end of the fastener; and removing the device from thepatient's abdominal cavity.
 17. The method of claim 16, whereinoperating the trigger causes the first insertion member to extended outfrom the shaft and curve to guide the fastener through the hernia mesh.18. The method of claim 17, wherein when the pair of prongs ispositioned together within the recess, the distal tip of the firstinsertion member defines an opening corresponding to a loop of the loopend.
 19. The method of claim 18, wherein the distal tip of the firstmember comprises a super-elastic material that biases the pair of prongstogether, and when the first insertion member is withdrawn from therecess, the pair of prongs are opened by being dragged over the secondmember.
 20. The method of claim 19, wherein retraction of the firstmember includes removing the pair of prongs from the recess andwithdrawing the distal tip of the first insertion member by allowing thehook end of the fastener to pass through the gap between the pair ofprongs.